Hypothesis is that elderly patients, acutely admitted for hip fracture, treated with melatonin for 5 days will experience less delirium than patients treated with placebo.
ID
Bron
Verkorte titel
Aandoening
Delirium
Hip Fracture
Elderly
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Delirium diagnosed within 8 days after start of the study medication.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Hypothesis is that elderly patients, acutely admitted for hip fracture, treated with melatonin for 5 days will experience less delirium than patients treated with placebo.
Onderzoeksopzet
At inclusion patiente will be asked to fill in different questionaire's to asses cognitive function and activities of daily living (KATZ score, IQ-scoree, MMSE, hand-grip strenght).
At 3 months and 12 months after hospital admission patients will be visited at home for assesment of cognitive and functional decline.
Onderzoeksproduct en/of interventie
Patients included in the MAPLE A stduy will be assigned to receive either melatonin 3 mg or placebo for 5 consequtive days.
Daily check-up will take place for evaluation of delirious symptoms, using the CAM score.
Algemeen / deelnemers
Internal-Geriatric Department
Academic Medical Center
Meibergdreef 9
S.E. Rooij, de
Amsterdam 1105 AZ
The Netherlands
(31)205669325
Wetenschappers
Internal-Geriatric Department
Academic Medical Center
Meibergdreef 9
S.E. Rooij, de
Amsterdam 1105 AZ
The Netherlands
(31)205669325
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age: 65 years or older;
2. Acute admission for surgical repair of hip-fracture;
3. Patiente must be willing and medically able to take the study medication;
4. Patients must be able to give informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients who can't speak / understand Dutch;
2. Patients transferred for surgical repair from another hospital.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1506 |
| NTR-old | NTR1576 |
| Ander register | 2008-000996-57 : EudraCT |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |